BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2EZEE

    MDR report key: 8784744 · Received July 12, 2019

    Report

    Report Number
    3002590791-2019-00003
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    June 17, 2019
    Report Date
    July 12, 2019
    Manufacturer
    GENICON
    Product Code
    GCJ
    UDI-DI
    00877972007289
    PMA / PMN Number
    K180836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    WITH ONLY THE NARRATIVE PROVIDED, IT APPEARS THAT THE FAILURE WAS RELATED TO USER ERROR - APPLYING TOO MUCH PRESSURE DURING THE REMOVAL PROCESS. HOWEVER, GENICON FULLY INVESTIGATED THE ISSUE AND THE RESULTS ARE BELOW. THE INVESTIGATION FOCUSED ON THE INTEGRITY OF THE MATERIAL. THE BLUE MATERIAL GOES THROUGH INCOMING INSPECTION PER INTERNAL SPECIFICATIONS. THE MATERIAL WAS RECEIVED APPROPRIATELY WITH ALL CERTIFICATES OF COMPLIANCE AND PASSED THE INTERNAL INSPECTION REQUIREMENTS. AS DISCUSSED ABOVE, THE MATERIAL WENT THROUGH APPROPRIATE INCOMING INSPECTION. IN THE PAST WHEN GENICON HAS RECEIVED BAG BREAK COMPLAINTS IT IS RELATED TO SHARP OBJECTS NEAR THE BAG CAUSING PUNCTURES. ANOTHER CAUSE COULD BE PRESSURE PLACED ON THE BAG OVER THE RECOMMENDED FORCE. THE FOLLOWING WARNINGS ARE FOUND IN THE IFU (2EZEE_AB): CARE SHOULD BE TAKEN TO AVOID CONTACT OF THE BAG WITH SHARP INSTRUMENTS, CUTTING DEVICES, AND ELECTROSURGICAL AND LASER INSTRUMENT. THIS DEVICE IS NOT INTENDED FOR USE WITH ANY TISSUE THAT WILL NOT FIT WITHIN THE CONFINES OF THE SPECIMEN BAG AND ALLOW COMPLETE CLOSURE OF THE BAG. DO NOT ATTEMPT TO REMOVE THE SPECIMEN THROUGH THE TROCAR OR CANNULA AS THIS MAY LEAD TO BAG RUPTURE AND SPILLAGE OF CONTENTS. EXCESSIVE FORCES SHOULD BE AVOIDED DURING BAG EXTRACTION TO AVOID ANY BAG STRETCHING OR TEARING. IF THE BAG AND ITS CONTENTS ARE TOO LARGE TO BE EXTRACTED, CAREFULLY ENLARGE THE ACCESS SITE TO FACILITATE EASY BAG REMOVAL. NOTE: IF THE BAG AND ITS CONTENTS ARE TOO LARGE TO BE EXTRACTED, CAREFULLY ENLARGE THE ACCESS SITE TO FACILITATE EASY BAG REMOVAL. GENICON REVIEWED THE HZD ANALYSIS IN REGARDS TO MISUSE AND FOUND THAT THE RISK HAS BEEN MITIGATED AS FAR AS POSSIBLE, EVEN INCLUDING THIS INCIDENT. AT THIS TIME, GENICON IS CLOSING THE COMPLAINT AS A SINGULAR OCCURRENCE, WITH THE ROOT CAUSE NOT COMPLETELY DETERMINED. GENICON WILL CONTINUE TO TREND COMPLAINT DATA DURING THE POST MARKET CLINICAL FOLLOW UP TO ENSURE THAT THE HIGHEST QUALITY PRODUCTS ARE ON THE MARKET.

    Description of Event or Problem · 1

    J0350-A [SIC] LAP CHOLE CASE ON MON (B)(6) 2019. A VERY UPSET DR (B)(6) TEXTED PHOTO OF A SMALL TIP OF POLY BAG FROM THE 2 EZEE THAT BURST UPON REMOVAL OF BALL BLADDER WITH LARGE STONE TO PAM GOWER (CRD). SHE CALLED ME AND PRINTED PHOTO. THE BAG IS IN A HAZARDOUS LABELED (B)(6) AND WAS SENT TO HOSPITAL SAFETY DEPT. THE SCRUB TECH ON THE CASE, (B)(6), REPORTED TO ME THAT DR (B)(6) FOLLOWED THE IFU STEPS CORRECTLY AND WAS WIDENING THE TROCAR SITE TO REMOVE BAG, THEN BAG GAVE WAY, DISTAL END RIPPED. ONLY UNDER LIGHT OF LAPAROSCOPIC CAMERA COULD THEY SEE SMALL PLASTIC BIT OF BAG. HAD THEY NOT NOTICED, IT MIGHT HAVE BEEN LEFT BEHIND. IT WAS APPROX THE SIZE OF HER PINKY FINGERTIP. J0324-A [SIC] BAG TORE DURING REMOVAL AND SMALL PIECE OF PLASTIC WAS STILL IN ABDOMEN. DR. REMOVED PLASTIC WITH GRASPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579148 2EZEE SPECIMEN RETRIEVAL BAG GCJ GENICON 550-000-200 J0350-A AND J0324-A 00877972007289

    Patients

    Seq Age Sex Outcome Treatment
    1 Other